Health TrialsbyHealthPanel

Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)

ConditionThymic Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

The goal of this clinical trial is to learn the role of adjuvant chemotherapy for patients with thymic carcinoma and completed resection. The main questions it aims to answer are:

1. Does adjuvant chemotherapy decrease disease progression? 2. Does medium dose of three drugs (paclitaxel, cisplatin, 5-FU) well tolerance?

Researchers will compare chemoradiotherapy to radiotherapy to see whether chemoradiotherapy could decrease disease progression or not.

Participants will:

1. Take radiotherapy (50Gy/25f) with or without 4 cycles of chemotherapy (TPF). 2. Follow up every 3 months in the first two year, and then every 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate and sign an informed consent form in writing;

Age range from 18 to 75 years old, regardless of gender;

Within 3 months after the surgery is completed;

Histologically diagnosed with thymic cancer;

Disqualifiers

Having a second primary tumor (excluding cured non malignant melanoma of the skin, papillary thyroid carcinoma, stage I seminomatoma, cervical carcinoma in situ, or other curable tumors that have been tumor free for more than 3 years after treatment);

Symptomatic coronary heart disease, left heart failure, uncontrollable seizures, or loss of self-awareness due to mental illness;

Pregnancy and lactation period;

Patients with drug addiction, chronic alcoholism and AIDS;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w.

  • Radiotherapy

    Radiation

    IMRT, 50Gy/25f

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: Radiotherapy ArmActive comparator 1 intervention
Group B: Chemoradiotherapy ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease free survival

From surgery to any disease relapse or death

Time frame
3 year

Secondary outcomes

1

Overall survival

from surgery to any death

Time frame
3 year
2

Disease Specific Survival

from surgery to death related to thymic carcinoma

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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